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Pediatric clinical drug trials in low-income countries: key ethical issues
S M MacLeod1, D C Knoppert, M Stanton-Jean
1Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada, smacleod@cfri.ca.
Insights
Protecting vulnerable children in low-income countries is crucial for ethical clinical research. Strengthening research ethics boards and fostering partnerships ensures children benefit from medical advancements.
Area of Science:
- Global Health
- Bioethics
- Pediatric Research
Background:
- Children in low-income countries face vulnerabilities including poverty, high disease rates, and cultural differences, impacting their participation in clinical research.
- Despite these challenges, vulnerability should not prevent children from accessing potential health benefits from ethical clinical research.
- There's a growing need for principles to guide pediatric clinical investigations in developing nations, ensuring protection from substandard treatments.
Purpose of the Study:
- To address the ethical considerations of conducting clinical research involving child participants in low-income countries.
- To propose strategies for stimulating ethically sound research that meets the clinical needs of children in developing nations.
- To ensure children in low-income countries are not excluded from the benefits of therapeutic advancements.
Main Methods:
- This review synthesizes current ethical challenges and proposes actionable strategies for improving clinical research involving children in low-income settings.
- Key recommendations include enhancing research ethics boards, building collaborative partnerships, strengthening capacity, improving consent processes, and developing harmonized ethics governance.
- The review emphasizes the need for international support and a culture of solidarity between developed and low-income countries.
Main Results:
- Children in low-income countries represent a significant demographic (39% are 13 or younger), necessitating frequent clinical investigations.
- Effective ethical consideration requires improvements in research ethics boards, stakeholder partnerships, capacity building, consent procedures, and governance.
- Strengthening research ethics infrastructure is vital for protecting child participants.
Conclusions:
- Ethically sound clinical research is essential for advancing pediatric therapeutics and ensuring children in low-income countries benefit from medical progress.
- International collaboration and sustained support are required to establish and maintain robust ethical oversight for pediatric clinical trials.
- Fostering true partnerships between global and local organizations is key to equitable participation and benefit-sharing in clinical research.
Abstract:
Potential child participants in clinical research trials in low-income countries are often vulnerable because of poverty, high morbidity and mortality, inadequate education, and varied local cultural norms. However, vulnerability by itself must not be accepted as an obstacle blocking children from the health benefits that may accrue as an outcome of sound clinical research. As greater emphasis is placed on evidence-based treatment of children, it should be anticipated that there will be a growing call for agreement on principles to guide clinical investigations in low-income countries. There is now general acceptance of the view that children must be protected from non-evidence-based interventions and from substandard treatments. The questions remaining relate to how best to stimulate clinical research activity that will serve the needs of infants, children, and youth in developing countries and how best to assign priority to ethically sound research that will meet their clinical requirements. In low-income countries, 39 % of citizens are 13 years of age or younger, and consequently it is certain that clinical investigations of some new therapeutic products will be conducted there more frequently. This review offers some suggestions for approaches that will help to achieve more effective ethical consideration, including (1) improving the quality of research ethics boards; (2) fostering collaborative partnerships among important stakeholders; (3) making concerted efforts to build capacity; (4) improving the quality of the consent and waiver process; and (5) developing improved governance for harmonized ethics platforms. Continuing support by international organizations is required to sustain the establishment and maintenance of stronger research ethics boards to protect children enrolled in clinical trials. This review underscores the importance of developing a culture of solidarity and true partnership between developed and low-income country organizations, which will allow all those involved, and especially child patients, to benefit from the advancement of therapeutics.
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